MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Model Number	04.617.814
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: ove.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the surgeon needed to do a revision of a c3-5 anterior cervical discectomy and fusion due to a c5 nerve palsy that the patient presented with post op from his original surgery four weeks prior.The original surgery was completed at (b)(6) on (b)(6) 2021.The patient suffered a fall in the bathtub and upon further ct diagnostic imaging, it appeared that the screws from the zero-p natural plate pulled out of c4 and were floating anterior to an adjacent vectra plate.The surgeon removed the floating screws and all existing hardware to assess the c5 nerve palsy then re-instrumented from c3-5 with new hardware.The screws from the zero-p natural plate loosened from the plate postoperatively.It is unknown if there is surgical delay reported.This report is for one (1) 3.0mm ti cervical spine locking screw 14mm.This is report 2 of 3 for (b)(4).

• Brand Name: 3.0MM TI CERVICAL SPINE LOCKING SCREW 14MM
• Common Device Name: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11437249
• Report Number: 2939274-2021-01231
• Device Sequence Number: 11647527
• Product Code: KWQ
• UDI-Device Identifier: 10705034742274
• UDI-Public: 10705034742274
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.617.814
• Device Catalogue Number: 04.617.814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR